NOBIVAC® RL

FOR ANIMAL USE ONLY

NOBIVAC® RL
Reg.No. G2199 (Act 36/1947)
Namibia Reg. No. V97/24.1/891 NS0

Only for use by or under the supervision of persons registered or authorised in terms of section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982).

Rabies is a notifiable disease in terms of the Animal Diseases Act (Act 35 of 1984). The occurrence or suspicion of this disease must be reported to the responsible State Veterinarian.

INDICATIONS
Nobivac® RL is an inactivated vaccine for the active immunisation of healthy dogs against rabies and canine leptospirosis caused by Leptospira interrogans serogroups canicola and icterohaemorrhagiae.

TARGET SPECIES
Dogs

COMPOSITION
Each 1 mℓ dose of Nobivac® RL contains at least 3 IU, as measured in the mouse potency test, of rabies virus strain Pasteur RIV, grown on cell culture and inactivated with β-Propiolactone, as well as BPL-inactivated Leptospira interrogans serogroup canicola, strain Ca-12-000 ≥ 40 hamster PD80 and Icterohaemorrhagiae, strain 820K ≥ 40 hamster PD80 with
2 % aluminium phosphate as an adjuvant and thiomersal as a preservative.

STORAGE
• Store in the dark between 2 °C and 8 °C.
• Do not freeze.
• Allow the vaccine to reach room temperature (20 °C to 25 °C) gradually before use.
• Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
• Protect from direct sunlight.

WARNINGS
• Occasionally a mild hypersensitivity reaction may occur after vaccination as is possible after administration of any foreign protein. Such reactions are in most cases self-limiting. A local reaction of limited size may arise during the first few days after vaccination.
• Destroy any unused, reconstituted vaccine, empty vaccine containers, needles, etc., according to local waste disposal regulations, after the completion of vaccination.
• Use the entire contents of the multi dose vial within one working day. Do not store partially used vaccine containers for future use.
• Nobivac® RL can be used to reconstitute the freeze-dried live Nobivac® canine vaccines (No information is available on the effects of the concurrent use with any other vaccines. It is therefore recommended that vaccines other than the live Nobivac® canine vaccines are not administered within 14 days before or after vaccination).
• KEEP OUT OF REACH OF CHILDREN, UNIFORMED PERSONS AND ANIMALS.
• Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS
• Vaccinate healthy dogs only.
• Adequate clinical examination should be done prior to inoculation.
• Following vaccination, contact with potential sources of infection should be avoided until 14 days after inoculation.
• Observe aseptic precautions. Ensure that the vaccination equipment (needles, syringes, etc.) are clean and sterile prior to use.
• Ensure that all the vaccination equipment remains clean and sterile during the vaccination process.
• It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED
Allow the vaccine to reach room temperature (20 °C to 25 °C) gradually before use.
Shake well before use.
Give 1 mℓ subcutaneously in the neck or chest region.
Nobivac® RL may be mixed or may be used as a diluent for Nobivac® DHP or Nobivac® DHPPi.

Vaccination programme
The primary vaccination against rabies is a single administration not given before 12 weeks of age. The primary vaccination may be administered at an earlier age, but then a repeat vaccination must be given at approximately 12 weeks, 2 to 4 weeks after the first vaccination.
The primary vaccination against leptospirosis should consist of 2 vaccinations, 2 to 4 weeks apart. Puppies should be at least 8 weeks of age before they receive the first vaccination against leptospirosis.

Therefore Nobivac® RL can be used under the following circumstances:

Puppies (early start)
Age 8/9 weeks Nobivac® Lepto or Nobivac® RL (in case of possible early exposure to rabies)
Age 12 weeks Nobivac® RL (repeat vaccination with rabies to ensure protection of puppies with maternal immunity against rabies)

Primary vaccination at any age ≥ 12 weeks
Age 12 weeks Nobivac® RL
Age 14/15 weeks Nobivac® Lepto

Proposed vaccination schedule
Depending on the local situation and the maternal immunity status of the animal, a choice can be made from the following vaccination programmes:

No direct infection risk:
Age 9 weeks Nobivac® Lepto and Nobivac® DHPPi
Age 12 weeks Nobivac® DHPPi and Nobivac® RL
In healthy dogs this programme will provide full protection against all components included.

Risk of parvovirus infection in weaned puppies:
Age 9 weeks Nobivac® DHPPi and Nobivac® Lepto
Age 12 weeks Nobivac® DHPPi and Nobivac® RL
The first vaccination at 9 weeks will protect 90 % of the pups against parvovirus disease. The second vaccination will provide full protection against all components included.

Risk of parvovirus and distemper infection in non-weaned puppies:
Age 6 weeks Nobivac® Puppy DP
Age 9 weeks Nobivac® DHPPi and Nobivac® Lepto
Age 12 weeks Nobivac® DHPPi and Nobivac® RL
The first vaccination at 6 weeks will provide protection against parvovirus disease in 75 % of the pups, the second one will increase this percentage to 95 %, and the third vaccination will provide full protection against all components.

Revaccination
Revaccination against rabies should be given every 3 years but local regulations may require earlier revaccination.
Revaccination against leptospirosis is needed every year. It is advocated to revaccinate against leptospirosis in the spring because infections with Leptospirae occur most frequently during late summer, and to give dogs that are often in natural water a third leptospirosis vaccination 6 months after the basic vaccination.

Revaccinations
Annually against leptospirosis Nobivac® Lepto
Every 3 years against rabies Nobivac® RL (or sooner to comply with local regulations)

PRESENTATION
Polyethylene terephthalate (PET) tray containing 10 single dose vials.
Multi dose vials containing 10 doses.

REGISTRATION HOLDER MANUFACTURER
Intervet South Africa (Pty) Ltd. Intervet International B.V.
20 Spartan Road Wim de Körverstraat 35
Spartan, 1619, RSA 5831AN Boxmeer
Tel: +27 (0) 11 923 9300 The Netherlands
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT
13 September 2006
 
SLEGS VIR DIEREGEBRUIK
Nobivac® RL
Reg. Nr. G2199 (Wet 36/1947)
Namibië Reg. Nr. V97/24.1/891 NS0

Slegs vir gebruik deur of onder die toesig van persone wat geregistreer of goedgekeur
is in terme van Afdeling 23 (1) (c) van die Wet op Veterinêre en Para-Veterinêre Beroepe, 1982 (Wet Nr. 19 van 1982).

Hondsdolheid is ‘n aanmeldbare siekte ingevolge die Wet op Dieresiektes (Wet 35 van 1984). Die voorkoms of vermoede van die siekte moet gerapporteer word aan die verantwoordelike staatsveearts.

INDIKASIES
Nobivac® RL is ‘n geïnaktiveerde entstof vir die aktiewe immunisering van gesonde honde
teen hondsdolheid en hondeleptospirose veroorsaak deur Leptospira interrogans serogroepe canicola en icterohaemorrhagiae.

TEIKENSPESIE
Honde

SAMESTELLING
Elke 1 mℓ dosis Nobivac® RL bevat ten minste 3 IE, soos gemeet in die muiskragtigheidstoets van hondsdolheidvirusstam Pasteur RIV, wat op selkulture gegroei is en geïnaktiveer is met β-Propiolaktoon, en bevat ook BPL-geïnaktiveerde Leptospira interrogans serogroep canicola, stam Ca-12-000 ≥ 40 hamster PD80 en icterohaemorrhagiae, stam 820K ≥ 40 hamster PD80 met aluminiumfosfaat as ‘n adjuvant en tiomersal as ‘n preserveermiddel.

BERGING
• Berg in die donker tussen 2 °C en 8 °C.
• Moenie vries nie.
• Laat die entstof toe om geleidelik kamertemperatuur (20 °C tot 25 °C) te bereik voor gebruik.
• Vermy langdurige of herhaalde blootstelling aan hoë omgewingstemperature nadat die entstof uit die yskas gehaal is, voor gebruik.
• Beskerm teen direkte sonlig.

WAARSKUWINGS
• Soms mag ‘n ligte hipersensitiwiteitsreaksie na inenting voorkom soos dit moontlik is na die toediening van enige vreemde proteïen. Sulke reaksies is selfbeperkend in die meeste gevalle. ‘n Plaaslike reaksie van beperkte grootte mag gedurende die eerste paar dae na inenting voorkom.
• Vernietig alle ongebruikte entstof, leë entstofhouers, naalde ens., in ooreenkoms met plaaslike afvalbestuursregulasies, na die inenting voltooi is.
• Gebruik die hele inhoud van die multidosisflessie in 1 werksdag. Gedeeltelik gebruikte houers moenie vir latere gebruik gebêre word nie.
• Nobivac® RL kan gebruik word om die gevriesdroogde lewende Nobivac® hondentstowwe her saam te stel. (Geen inligting is beskikbaar oor die gelyktydige gebruik met enige ander entstowwe nie. Dit word daarom aanbeveel dat entstowwe anders as die lewende Nobivac® hondentstowwe nie toegedien word vir ten minste14 dae voor of na inenting nie).
• HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
• Alhoewel hierdie entstof breedvoerig onder ‘n wye verskeidenheid toestande getoets is, mag dit faal as gevolg van verskeie redes. Indien dit vermoed word, raadpleeg ‘n veearts en verwittig die registrasiehouer.

 
VOORSORGMAATREëLS
• Net gesonde honde mag ingeënt word.
• Bevredigende kliniese ondersoeke moet gedoen word voor inenting.
• Aanraking met potensiële bronne van infeksie moet vir tot 14 dae na inenting vermy word.
• Aseptiese voorsorgmaatreëls moet gehandhaaf word. Daar moet verseker word dat alle inentingstoerusting (naalde, spuite ens.) skoon en steriel is voor gebruik.
• Sorg dat alle toerusting skoon en steriel gehou word gedurende inenting.
• Dit is goeie inentingspraktyk, wanneer entstowwe hanteer word, om kontak met die oë, hande en klere te vermy.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI
Laat die entstof toe om geleidelik kamertemperatuur (20 °C tot 25 °C) te bereik voor gebruik.
Skud goed voor gebruik.
Dien 1 mℓ onderhuids toe, in die nek- of borskasarea.
Nobivac® RL mag gemeng word of mag as ‘n oplosmiddel vir Nobivac® DHP, Nobivac® DHPPi gebruik word.

Inentingsprogram
Die primêre inenting teen hondsdolheid is ‘n enkele toediening wat nie voor ‘n ouderdom van
12 weke gegee moet word nie. Die primêre inenting mag op ‘n vroeër ouderdom gegee word
maar dan moet ‘n herhaling teen ongeveer 12 weke, 2 tot 4 weke na die eerste inenting
gedoen word.
Die primêre inenting teen leptospirose behoort uit 2 toedienings, 2 tot 4 weke uitmekaar
te bestaan. Klein hondjies behoort ten minste 8 weke oud te wees voordat hulle die eerste
inenting teen leptospirose ontvang.

Daarom kan Nobivac® RL in die volgende omstandighede gegee word:

Klein hondjies (vroeë begin)
8/9 weke oud Nobivac® Lepto of Nobivac® RL (in geval van moontlike vroeë blootstelling aan hondsdolheid).
12 weke oud Nobivac® RL (herhaling met hondsdolheid om beskerming van die klein hondjies met passiewe immuniteit teen hondsdolheid te verseker).

Primêre inenting teen enige ouderdom ≥ 12 weke
12 weke oud Nobivac® RL
14/15 weke oud Nobivac® Lepto

Voorgestelde inentingskedule
Afhangend van die plaaslike toestande en die passiewe immuniteit van die dier, kan ‘n keuse tussen die volgende inentingsprogramme gemaak word:

Geen direkte infeksie risiko:
9 weke oud Nobivac® Lepto en Nobivac® DHPPi
12 weke oud Nobivac® DHPPi en Nobivac® RL
In gesonde honde sal hierdie program volle beskerming teen alle ingeslote komponente bied.

Risko van parvovirus-infeksie in gespeende hondjies:
9 weke oud Nobivac® DHPPi en Nobivac® Lepto
12 weke oud Nobivac® DHPPi en Nobivac® RL
Die eerste inenting op 9 weke sal beskerming aan 90 % van die hondjies teen parvovirus bied. Die tweede inenting sal volle beskerming teen alle ingeslote komponente bied.

 
Risiko van parvovirus en hondesiekte in nie-gespeende hondjies:
6 weke oud Nobivac® Puppy DP
9 weke oud Nobivac® DHPPi en Nobivac® Lepto
12 weke oud Nobivac® DHPPi en Nobivac® RL
Die eerste inenting teen 6 weke sal beskerming teen parvovirus aan 75 % van die hondjies
bied, die tweede 1 sal die persentasie tot 95 % verhoog, terwyl die derde inenting volle
beskerming teen alle komponente sal bied.

Herinenting
Herinenting teen hondsdolheid moet elke 3 jaar gegee word, maar plaaslike regulasies mag
vroeër herinenting vereis.

Herinenting teen leptospirose word elke jaar benodig. Dit word aanbeveel om [her]inenting
teen leptospirose in die lente te doen aangesien Leptospira infeksies baie dikwels gedurende [laat] somer voorkom en om aan honde wat dikwels in natuurlike water kom, ‘n derde leptospirose inenting 6 maande na die basiese inenting te gee.

Herinenting
Jaarliks teen leptospirose Nobivac® Lepto
Elke 3 jaar teen hondsdolheid Nobivac® RL (of vroeër om aan plaaslike regulasies te voldoen).

AANBIEDING
Poliëtileen (PET) houers wat 10 enkeldosisflessies bevat.
Multidosisflessies wat 10 dosisse bevat.

REGISTRASIEHOUER VERVAARDIGER
Intervet South Africa (Pty) Ltd. Intervet International B.V.
Spartanweg 20 Wim de Körverstraat 35
Spartan, 1619, RSA 5831AN Boxmeer
Tel: +27 (0) 11 923 9300 The Netherlands
Faks: +27 (0) 11 392 3158
www.msd-animal-health.co.za

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET
13 September 2006